Cleared Traditional

K873760 - SUPERPULSE AMBULASE (XAM-SP) CO2 SURGIC...

K873760 is the FDA 510(k) clearance for SUPERPULSE AMBULASE (XAM-SP) CO2 SURGIC... by Coherent Medical Group. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K873760 · Coherent Medical Group · General & Plastic Surgery device
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Nov 1987
Decision
72d
Days
Class 2
Risk

K873760 is an FDA 510(k) clearance for the SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Coherent Medical Group (Palo Alto, US). The FDA issued a Cleared decision on November 27, 1987 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coherent Medical Group devices

Submission Details

510(k) Number K873760 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 16, 1987
Decision Date November 27, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1174
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K873760.
INFRAGUIDE(TM)
K875115 · Cooper Lasersonics, Inc. · Feb 1988
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY
K873790 · Cooper Lasersonics, Inc. · Jan 1988
ULTRASPOT MICROMANIPULATOR
K873443 · Cooper Lasersonics, Inc. · Jan 1988
CODMAN NEUROLASE LASER SYSTEM
K872179 · Codman & Shurtleff, Inc. · Oct 1987
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
K872711 · Directed Energy, Inc. · Sep 1987
LPM-1 (LASER POWER METER)
K871619 · Bio-Tek Instruments, Inc. · Jul 1987